BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15090130 · Received July 22, 2022

    Report

    Report Number
    2955842-2022-13111
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 23, 2022
    Report Date
    June 22, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE RIGHT MASTER TOOL MANIPULATOR (MTMR) WAS REPLACED TO RESOLVE THE ERRORS THAT WERE REPORTED. AFTER REPLACEMENT, THE SYSTEM WAS TESTED OPERATED WITHOUT ERROR AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE MTM FOR EVALUATION, BUT IT HAS NOT YET BEEN COMPLETED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED FOLLOWING COMPLETION OF THE INVESTIGATION A LOG REVIEW CONFIRMED THE PROCEDURE DATE OF (B)(6) 2022 ON SYSTEM SK3998. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO ERROR MESSAGES IN THE SURGEON SIDE CONSOLE (SSC). WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MASTER TOOL MANIPULATOR (MTM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS COULD NOT REPLICATE THE CUSTOMER REPORTED COMPLAINT OF ¿SURGEON SIDE CONSOLE (SSC) 1 FAILED SELF TEST AND DISPLAYED ERRORS 23025,23009,23008 AND 23013 ON AXIS 2." HOWEVER, THE ISSUE WAS CONFIRMED AS HAVING OCCURRED VIA FIELD ERROR LOGS. VISUAL INSPECTION WAS PERFORMED. THE MTM2 WAS INSTALLED ONTO THE SYSTEM AND POWERED UP. SINE CYCLE AND A TEST DRIVE WERE PERFORMED WITHOUT ANY ISSUES. TESTS PERFORMED VIA DATA TERMINAL EQUIPMENT (DTE) AND MATLAB PASSED. THE FOLLOWING PARTS WILL BE REPLACED AS A PRECAUTION: A2 MOTOR CABLE, AXIS 2 POT, AXIS 2 MOTOR. ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H2, AND H3. FAILURE ANALYSIS INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: H6 AND H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED TECHNICAL SUPPORT TO STATE THAT THE SURGEON SIDE CONSOLE (SSC) 1 RIGHT MASTER TOOL MANIPULATOR (MTMR) FAILED SELF-TEST UPON POWER ON. SEVERAL ERRORS INCLUDING 23008, 23009, 323013, AND 23025 DISPLAYED ON THE TOUCHSCREEN AND HARD POWER CYCLE SYSTEM DID NOT RESOLVE THE ISSUE. AN ISI TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE CUSTOMER TO CHECK WHICH AXIS DISPLAYED THE ERROR AND CONFIRM THE SSC SERIAL NUMBER. HOWEVER, THE CUSTOMER WAS NOT ONSITE AT THE TIME OF THE EVENT AND UNABLE TO PERFORM THE TROUBLESHOOTING. THE CUSTOMER ELECTED TO USE THE SSC 2 TO CONTINUE THE PROCEDURE AS THIS WAS THE FIRST TIME THAT THEY EXPERIENCED THIS ISSUE. THE PROCEDURE WAS CONVERTED TO ANOTHER DV WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON AND ERROR 23008 APPEARED. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS (E.G. UNEXPECTED BLEEDING, ANASTOMOTIC LEAK, BLADDER/URETER DAMAGE, NERVE DAMAGE ETC.) OBSERVED. THE CUSTOMER PROCEEDED WITH THE 2ND CONSOLE NORMALLY AND THE PATIENT HAD NO INJURY/HARM. VIDEO RECORDING OF THE PROCEDURE WAS NOT AVAILABLE FOR ISI REVIEW. INFORMATION REGARDING PATIENT RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116615 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-22 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES